MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025)

This guidance is applicable to all medical devices and in vitro diagnostic medical devices. The main objectives of this guidance are to describe: the post-market surveillance (PMS) system and the PMS plan, the main activities within the PMS system, and to clarify the interactions of the PMS system in accordance with Article 83 MDR/Article 78 IVDR with other key aspects of the QMS as described in Article 10(9) MDR and Article 10(8) IVDR. Read the news published by EC Directorate-General for H...